A Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, PK/PD Characteristics, and Efficacy of SCTB10

Korábbi kezelés

• Abnormal results in urine drug screening or breath alcohol test.
• Use of any medication or dietary supplements within 14 days prior to the first dose.
• Participation in another clinical trial involving the use of any investigational drug or medical device within 12 weeks prior to screening.
• Receipt of any biologic products (including antibodies or their derivatives) within 16 weeks prior to dosing (or within 5 half-lives, whichever is longer).

Más betegség

• History of hypersensitivity or allergy to monoclonal antibodies, or a known atopic constitution.
• History of coronary and/or peripheral atherosclerosis, or congestive heart failure.
• Presence of high-risk factors for thrombosis.
• Abnormal infectious disease screening results.

Egyéb

• Clinically significant abnormal findings during screening, as determined by the investigator.

• Provision of written informed consent prior to initiation of any study procedures.
• Healthy male participants aged 18 to 50 years (inclusive).
• Body mass index (BMI) between 19 and 26 kg/m² (inclusive), and body weight ≥ 50 kg.
• Agreement by the participant and their partner to use highly effective contraception during the study period and for 6 months following the last dose of study medication.